ExStroke Pilot Trial of the effect of repeated instructions to improve physical activity after ischaemic stroke: a multinational randomised controlled clinical trial

doi:10.1136/bmj.b2810

Published 22 July 2009, doi:10.1136/bmj.b2810
Cite this as: BMJ 2009;339:b2810

Research

ExStroke Pilot Trial of the effect of repeated instructions to improve physical activity after ischaemic stroke: a multinational randomised controlled clinical trial

Gudrun Boysen, professor of neurology¹, Lars-Henrik Krarup, PhD student¹^,6, Xianrong Zeng, neurologist², Adam Oskedra, neurologist³, Janika Kõrv, neurologist⁴, Grethe Andersen, neurologist⁵, Christian Gluud, head of Copenhagen Trial Unit⁶, Anders Pedersen, study nurse¹, Marianne Lindahl, physiotherapist¹, Lotte Hansen, physiotherapist¹, Per Winkel, statistical adviser⁶, Thomas Truelsen, neurologist¹, for the ExStroke Pilot Trial Group

¹ Department of Neurology, Bispebjerg Hospital, Copenhagen University Hospital, Bispebjerg Bakke 23, DK-2400 Copenhagen NV, Denmark, ² Department of Neurology, Sichuan Provincial People’s Hospital, Chengdu, China, ³ Department of Neurology, Institute of Psychiatry and Neurology, Warsaw, Poland, ⁴ Department of Neurology and Neurosurgery, University of Tartu, Estonia, ⁵ Department of Neurology, Aarhus University Hospital, Denmark, ⁶ Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital

Correspondence to: G Boysen gb01{at}bbh.regionh.dk

Objectives To investigate if repeated verbal instructions aboutphysical activity to patients with ischaemic stroke could increaselong term physical activity.

Design Multicentre, multinational, randomised clinical trialwith masked outcome assessment.

Setting Stroke units in Denmark, China, Poland, and Estonia.

Participants 314 patients with ischaemic stroke aged $≥$ 40 yearswho were able to walk—157 (mean age 69.7 years) randomisedto the intervention, 157 (mean age 69.4 years) in the controlgroup.

Interventions Patients randomised to the intervention were instructedin a detailed training programme before discharge and at fivefollow-up visits during 24 months. Control patients had follow-upvisits with the same frequency but without instructions in physicalactivity.

Main outcome measures Physical activity assessed with the PhysicalActivity Scale for the Elderly (PASE) at each visit. Secondaryoutcomes were clinical events.

Results The estimated mean PASE scores were 69.1 in the interventiongroup and 64.0 in the control group (difference 5.0 (95% confidenceinterval –5.8 to 15.9), P=0.36. The intervention had nosignificant effect on mortality, recurrent stroke, myocardialinfarction, or falls and fractures.

Conclusion Repeated encouragement and verbal instruction inbeing physically active did not lead to a significant increasein physical activity measured by the PASE score. More intensivestrategies seem to be needed to promote physical activity afterischaemic stroke.

Trial registration Clinical Trials NCT00132483 [ClinicalTrials.gov]

© Boysen et al 2009
This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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